IRB Connection HSO Newsletter

 
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If you have questions regarding the newsletter and/or ideas for content, please contact the IRB Education and Outreach Program at irb-outreach@uiowa.edu 

 

2019

November Regulatory Newsletter

  • National Cancer Institute (NCI) funded research occurring at the Iowa City VAHCS
  • Announcing New Policies Regarding IBC Review
  • Other Committee Review Tool

October Regulatory Newsletter

  • From the Director and IRB Education Outreach Manager
  • What Does It Mean to be AAHRPP Accredited?
  • Investigator Guide Changes – Oct 2019 Regulatory Newsletter
  • New Educational Tool – Data Security
  • Coming Soon! A Change in the Assignment of HawkIRB ID Numbers

May

  • Welcome, New Faculty/Staff Researchers
  • Request a Presentation Now for your Research-Oriented Class or Group
  • Course-Related Student Projects
  • External IRB Review Process
  • Before You Go: PI Transfer/Departure Checklist

 

2018

IRB Regulatory and Policy Updates

  • Changes to the timing of IRB approval and Pharmacy & Therapeutics Investigational Drug Service approval
  • Changes to question V.22 that may impact research submissions
  • New Automated UI Health Care Clinical (UIHC) Trials and Research Website recruitment tool

October

  • Exploratory Workshop- Informed Consent
  • Research Ethics Reading List
  • Biorights: Subjects' Rights in Future Research

August

  • New Faculty/Staff Orientation to the IRB
  • Mass Email for Research Recruitment
  • IRB Member Recruitment: Seeking IRB Community Members
  • Protocol Changes or New Information: Remember to Re-Consent Subjects
  • The Role of Risk Management in Reviewing Human Subjects Research

June

  • Congratulations to Lori Dolan and Dixie Ecklund
  • 2018 Common Rule: Another 6-Month Delay for Compliance
  • Spanish Resources for the Protection of Research Participants
  • Deception Research: Withholding Information from Subjects

April

  • ClinicalTrials.gov Office Hours
  • Conflict of Interest Disclosure Deadline
  • Revised Common Rule Delay
  • Determining Capacity to Consent
  • Data Use Agreements
  • Research in the Early Modern Era
  • Herky Hints: HawkIRB Workflow and You
  • IRB Advisor, April 2018: The Search for Justice in the Human Genome

March

  • ClinicalTrials.gov Registration Tool
  • Hardin Library Exhibit about Human Subjects Research
  • New International Listing of Social/Behavioral Research Standards
  • Using UI Mass Email for Study Recruitment: The Top 5 Things Researchers Should Know
  • Expressing Appreciation and Reporting Concerns
  • Genetics and Research: New Frontiers, New Challenges
  • Herky Hints: How to Get Your HawkIRB Applications Approved Quicker

Regulatory/Policy Update

  • New Policy and Procedures: Documenting Research Participation in the UIHC Medical Record
  • Revised UI Health Care Policy and the Research Billing Compliance Process
  • Training Requirements Associated with the UI Health Care Policy Change

February

  • Updates to Federal Regulations/Guidance
  • HawkIRB Trainings, IRB Presentations, and Office Hours
  • Resources for New Researchers
  • IRB Education
  • HH: HawkIRB Delegate Permission System

2017

December

  • Feedback about IRB Educational Resources
  • Subversive Subjects in Clinical Trials
  • Clinical Trials.gov

November

  • Update to GCP Training Certificates
  • Mail-out Consent
  • Expanding Vulnerable Populations

October

  • ITS Update of Mass Email Policy
  • SBIR/STTR
  • Patient Advocacy Groups in Research
  • External/Commercial IRB Q&A 

September 

  • Summer Article Recap
  • CITI Training
  • PRIM&R: Informed Consent and the Revised Common Rule
  • Resources for Researchers

August

  • FDA Draft Guidance for Electronic Records and Signatures
  • Other Human Research Protection Program Committees & Units
  • Risk Communication and Consent

July

  • Enrolling Children in Research
  • Documentation of Informed Consent- Best Practices
  • International Research
  • Quality Assurance/Quality Improvement
  • External/Commercial IRB Q&A
  • HH: Accessing Medical Records for Recruitment Purposes

May

  • ClinicalTrials.gov Final Rule Updates
  • Changes in the HawkIRB Approval Tab
  • Changing PIs and RTMs in HawkIRB
  • External/Commercial IRB Q&A
  • HH: Funding Source Modifications

March

  • The New HawkIRB Carousel Index
  • External/Commercial IRB Q&A
  • VA/UI Research & Multiple Applications
  • Top Monitoring Findings of 2016

February

  • Feedback and Suggestions
  • IRB Presentations
  • Documenting Subject Agreement for Optional Research Activities

2016

December

  • Looking Back and Looking Forward
  • Ethical Principles Series- Justice
  • Umbrella Projects

November

  • Updates from the Director
  • Multisite Research with sIRB
  • Essentials of Central/External IRB
  • Commercial IRB
  • Navigating sIRB Reliance
  • External IRB Q & A
  • Herky Hints: HawkIRB with UI as Lead OR Relying IRB
  • IRB Advisor November 2016

October

  • Regulatory Updates from the Director
  • Ethical Principles Series -- Beneficence
  • Anonymity in Qualitative Research
  • Reportable Events
  • IRB Advisor Newsletter

September

  • Summer Article Recap
  • IRB Member Recruitment
  • Diversity in Online Research
  • Herky Hints: Contact People
  • Classroom Presentations
  • IRB Advisor Newsletter

August

  • Ethical Principles in Research - Respect for Persons
  • Course-Related Student Project Updates
  • Herky Hints: What to Review for your Continuing Review
  • A Measure of Our Performance: 2015 IRB Review Metrics
  • The IRB Advisor Newsletter, August 2016: NIH Clinical Center Riddled With Research Problems 

July

  • Updates from the Director
  • VII.B.1 Enhancements
  • Clinical Trials.gov registration and reporting
  • Research in Online Environments
  • Research Subject compensation Reminder
  • The IRB Advisor Newsletter, July 2016

June

  • The Central and External IRB Model of Oversight
  • Changes to the Continuing Review reminder
  • The IRB Advisor Newsletter, June 2016

May

  • Updates from the Director
  • Health Literacy and Therapeutic Misconception: Barriers to Informed Consent
  • Using Mobile Technologies to Address Barriers to Participation in Clinical Trials
  • IRB-04 Department of Defense: Announcing the UI’s Newest IRB
  • The IRB Advisor Newsletter, May 2016

March

  • Updates from the Director
  • Sex Bias and Clinical Trial - An Ongoing Concern
  • The IRB Advisor Newsletter: An educational resource
  • Got a Minute to Talk About IRB Meeting Minutes?

February

  • UI’s Institutional Conflict of Interest in Human Subjects Research
  • New FDA Site Inspection Guidance
  • Promises, Promise: I Assure You...What Exactly?
  • Using Social Media for Research Recruitment 

2015

December

  • HawkIRB Phase II Changes: Central and External IRB Models
  • Developing Your Data Management Plan
  • HawkIRB Hints: Breaking Down the Details of Risks

October

  • Changes to the HawkIRB Application: Phase 1
  • Underrepsentation in Clinical Trials: The Black Experience
  • HawkIRB Hints: YOU Can Prevent Reportable Events!

August

  • Back to School Special: Faculty Advisor Responsibilities
  • Attention Biomedical Researchers: New Type of PRMC Notice
  • HawkIRB Hints: Finding Your Way in HawkIRB

June

  • It’s OK to Delegate, but Remember… It’s Still Your Study!
  • How Do I…?  FAQ Page Links
  • HawkIRB Hints: How Do You Attach a Revised Document?

April

  • The Tattletale IRB
  • IRB Compliance Staff to attend FDA Audits
  • HawkIRB Hints: Best Kept Secret

February

  • "I didn't think it was Human Subjects Research because..."
  • UI policy on Mandatory Reporting of Physical and Sexual Abuse of Children: The Research Perspective
  • Conflict of Interest in Research-Implications for Investigators

2014

December

  • External IRBs incorporated into HawkIRB
  • Financial Interest Disclosure Reporting
  • News Flash

October

  • Financial Conflict of Interest in Research
  • Upcoming AAHRPP Site Visit
  • Subjects Who Are Lost to Follow-up
  • News Flash: HSO Interim Director appointment and staff departures

September

  • Keeping Current on International Research Regulations
  • Tips to Improve your Informed Consent Document
  • Mainline Questions: HawkIRB Workflow

August

  • Facebook's Controversial Sociological Study
  • A personal Note from the HSO director
  • Need help with HawkIRB? Herky Hints: Oops, I Made this Draft... Now What?
  • New Positions filled in the Human Subjects Office!

July

  • Research Misconduct, Prevention Strategies and More
  • Changes in IRB Determinations for Studies that Access PHI for Recruitment
  • Did You Know? – HSO Presentations
  • Who Should Be a Research Team Member?
  • Try Your Hand at Being an IRB Chair

June

  • A More Flexible IRB on the Horizon
  • Tips to Protect and Secure Information When Using Mobile Devices
  • News Flash: Relocation of the Conflict of Interest in Research Program
  • Need help with HawkIRB?  Herky Hints: Assurance Document

May

  • IRB Review of Qualitative Research – Just Jumping Through the Hoops?
  • A Change in Your Summer Plans? - Let us Know!
  • News Flash: HSO Staff Farewell
  • Need help with HawkIRB? Herky Hints: Dealing with HawkIRB email notifications

April - Research with Children Special Edition

  • Risk and IRB Review
  • Assent
  • Parental Permission  
  • Applicable Regulatory Definitions
  •  HawkIRB: Procedures for Obtaining Consent and Assent
  • Pregnancy in a Minor Subject Population

April

  • Describing Risk to Research Participants
  • Disclosing the Probability and Magnitude of Physical Risk
  • What We Did Last Month...Submitted an application for AAHRPP Re-Accreditation
  •  News Flash: Changes with HawkIRB and the CRU
  • This month in Human Subjects Protection History: The Belmont Report

March

  • Additional Requirements for DoD Research
  • Where is this CITI of which you speak, and what does it have to do with me?
  • Spring Break Reminder (submit your HawkIRB application/HSRD)
  • IRB Policy Revision: Revised Guidelines Regarding Payment and Compensation
  • What’s that Mean?: Certified IRB Professional

February

  • New Compliance Monitoring Programs Coming to a Study Near You
  • News Flash: HSO New Hours of Operation
  • IRB Policy Revision: Inclusion of Compensation Amount in Recruitment Materials
  • IRB Policy Reminder: Cold-Calling of Potential Subjects as a Recruitment Method

January - Reportable Events Special Edition (IRB-01/03) 
January - Reportable Events Special Edition (IRB-02) 

  • What are Reportable Events?
  • Serious Adverse Drug Events (IRB-01/03)
  •  Serious Adverse Device Effect (IRB-01/03)
  •  Reportable Events Q&A: Why do I need to submit REFs?
  • Receipt of New Information
  • Unanticipated Problems Involving Risks to Subjects or Others
  • Noncompliance
  • Preventing Reportable Events

January

  • Letter from the Editor
  •  Should I Submit a New Project Application or a Modification?
  • News Flash: Andy Bertolatus' retirement announcement
  • Back to School Reminder: Submit your HawkIRB Application

2013

December

  • Why is My Study Going to the Full Board?
  • Come to the Dark Side, we have cookies! (Working for the HSO)
  • What's that Mean?: Human Subjects Research Acronyms
  •  HawkIRB: How Do I Use the Inbox Filter?

November

  • The Informed Consent Process
  • Mainline Questions: Flavors of Waivers
  • Use of Short Form Consent Document for Non-English Speaking Subjects
  • Obtaining Required Signatures on the Informed Consent Document

October

  • Coercion and Undue Influence: What is the difference?
  • Mainline Questions: Alphabet Soup (HSO vs. IRB)
  • HawkIRB: How Do I Use the Delegate Permission System?
  • IRB Policy Reminder: Requirements for Completion of Optional Agreements

September

  • Mainline Questions: What does Exempt mean?
  • The Mailed Consent Process: What to do if there are errors?
  • Back to School: Human subjects research in the classroom
  • News Flash: Course-Related Student Project Policy Revision
  • IRB Policy Reminder: UI Students as Research Subjects

August

  • Enrolling Minors: What Happens When They Age Up?
  • HIPPA/HITECH Act Omnibus Final Rule
  • Human Subjects Research Data and Sample Identification Terms
  • IRB Policy Reminder: Case Report Forms (CRFs) Should not be attached to the HawkIRB Application
  • Have an idea for IRB Connection?

July- Genetic Research Special Edition

  • Federal Regulations and Guidance
  • Genetic Information Nondiscrimination Act (GINA)
  • Is it Genetic Research?
  • Incidental Findings

July

  • Top 5 Monitoring Findings of 2012
  • Mainline Questions: Do I have to fill out an IRB application?
  • HawkIRB: How do I find my Approval Memo?
  • Get to Know: The HSO Exec. Director and UI Institutional Official
  • News Flash: My Research Portal

June

  • Greetings from the HSO: Mainline Questions
  • New FDA Rule: Children in Clinical Investigations
  • IRB Policy: Compensation in Recruitment Materials
  • Get to Know: The Education and Compliance Staff

May

  • Plain Language Facilitating Subjects Understanding
  • Revisions to the Declaration of Helsinki
  • IRB Policy Reminder: Recording Additional Information on the Informed Consent Document
  • Issues to Consider when a PI leaves the UI
  • Get to Know: The IRB-02 Staff